Ultrasound systems and methods for orthopedic applications

ABSTRACT

Medical diagnostic instruments and systems are provided that include (i) a proximal handle configured and dimensioned to permit an operator to manually grasp the instrument; (ii) an ultrasound probe including a longitudinal shaft extending distally from the handle and terminating in a distal end, and an ultrasound transducer mounted with respect to the longitudinal shaft proximate the distal end thereof, the ultrasound transducer including an array of ultrasonic energy generation elements; and (iii) a tactile feeler probe mounted with respect to the ultrasound probe, the tactile feeler probe including a longitudinal shaft mounted with respect to the longitudinal shaft of the ultrasound probe and extending distally beyond the distal end thereof, and a feeler probe tip (e.g., a ball tip) defined at a distal end of the longitudinal shaft of the tactile feeler probe. Advantageous methods for use of the disclosed instruments and systems are also provided, e.g., for detecting breaches in cortical bones in connection with pedicle screw placement.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of a provisional patentapplication entitled “Ultrasound for Orthopedic Application” which wasfiled on May 7, 2009, and assigned Ser. No. 61/176,373. The entirecontent of the foregoing provisional application is incorporated hereinby reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to equipment and procedures inthe field of spinal surgery and, in exemplary implementations, toinstruments, systems and methods for positioning and/or evaluating thepositioning of pedicle screws in connection with orthopedicapplications.

2. Background Art

Surgical techniques for spinal fixation vary widely in terms of thetypes of surgical equipment used, but modern surgical practice continuesto rely quite heavily on the strength and stability afforded by thecommon pedicle screw. However, care must be taken during pedicle screwplacement to protect against nerve damage. For example, after forming apilot hole in the bone tissue of a pedicle but before moving forwardwith pedicle screw implantation, a surgeons will typically take theopportunity to inspect the axially-extending side walls of the pilothole to locate defects. With the advent and increasing use of minimallyinvasive surgical procedures that afford only a limited view withrespect to anatomical structure, the risk of misplaced pedicle screwshas increased. In the event a surgeon locates a breach of anysignificant size the cortical bone adjacent the spinal column, he or shewill mostly likely elect to redirect the screw to avoid the risk ofcomplications such as pain, paralysis and hemorrhaging.

One method for locating such cortical breaches in regular use bysurgeons is tissue palpation by means of the common tactile feelerprobe. While all surgeons are aware that this method has itslimitations, including with regard to sensitivity in the case ofrelatively small breaches, as well as with regard to false positives,many if not most have become comfortable with the use of the tactilefeeler probe. To the extent techniques and tools can be developed tofacilitate continued effective use of tactile diagnostic techniques inthe context of minimally invasive spinal surgical procedures, there islikely to be a strong market for same among current practitioners.

Recent developments in the use of ultrasound technology in surgicalapplications have shown promise. With the increasing miniaturization ofelectronics generally has come the ability to position ultrasoundtransducers to beneficial effect in increasingly smaller and, at leastup until recently, harder to reach anatomical locations. Nevertheless,and despite efforts to date, a need remains for convenient, sanitary,low-cost, and effective equipment and related techniques for locatingpilot hole bone tissue defects prior to pedicle screw implantation.

These and other needs are satisfied by the instruments, systems andmethods disclosed herein, as will be apparent from the detaileddescription which follows, particularly when read in conjunction withthe figures appended hereto.

SUMMARY

The present disclosure provides advantageous instruments, systems andmethods for obtaining and/or determining anatomical information, e.g.,locating pilot hole bone tissue defects prior to pedicle screwimplantation. In exemplary embodiments, a medical diagnostic instrumentis provided that includes (i) a proximal handle configured anddimensioned to permit an operator to manually grasp the instrument; (ii)an ultrasound probe including a longitudinal shaft extending distallyfrom the handle and terminating in a distal end, and an ultrasoundtransducer mounted with respect to the longitudinal shaft proximate thedistal end thereof, the ultrasound transducer including an array ofultrasonic energy generation elements; and (iii) a tactile feeler probemounted with respect to the ultrasound probe, the tactile feeler probeincluding a longitudinal shaft mounted with respect to the longitudinalshaft of the ultrasound probe and extending distally beyond the distalend thereof, and a feeler probe tip (e.g., a ball tip) defined at adistal end of the longitudinal shaft of the tactile feeler probe.

The ultrasound transducer and the distal end are generally cooperativelyconfigured, oriented, and dimensioned to permit the operator to insertthe ultrasound transducer and the distal end into a desired anatomicallocation to permit the operator to obtain thereat a correspondingtwo-dimensional image of the anatomical location for visual inspectionby the operator for purposes of detecting ultrasonically-detectableanatomical properties. The array of ultrasonic energy generationelements may be side-firing and may be oriented in a linear array or aphased array. In addition, the feeler probe tip and the longitudinalshaft of the tactile feeler probe are generally cooperatively configuredand dimensioned to permit the operator to insert the feeler probe tipand the longitudinal shaft of the tactile feeler probe into the desiredanatomical location to permit the operator to perform thereat a tactileinspection of the selected anatomical location.

The disclosed medical diagnostic instrument may be advantageouslyemployed in connection with a pedicle screw pilot hole formed in thespine of the human patient. In addition, the array of ultrasonic energygeneration elements of the ultrasound transducer may extend axiallyalong, and be positioned against, a selected portion of a side wall ofthe pedicle screw pilot hole. The feeler probe tip may be positionedagainst the selected portion of the side wall of the pedicle screw pilothole. The medical diagnostic instrument may also include at least onechannel configured and dimensioned to receive a K-wire to permit theinstrument to be slidably mounted thereto for purposes of guiding theultrasound and tactile feeler probes axially relative to the desiredanatomical location. Thus, the channel may be in the handle and extendtherethrough, and/or be formed in an extension of the handle and extendtherepast. The handle and the longitudinal shaft of the ultrasound probemay be of unitary construction or the ultrasonic probe may be mountedwith respect to the handle such that the longitudinal shaft of theultrasonic probe is supported, cantilever-style, by the handle housing.In addition, the tactile feeler probe may be mounted with respect to theultrasound probe such that the longitudinal shaft of the tactile feelerprobe is supported, cantilever-style, by the longitudinal shaft of theultrasound probe.

The disclosed medical diagnostic instrument is typically adapted tocooperate with a cable assembly for carrying electrical signals to andfrom the ultrasound transducer in accordance with an ultrasonic imagingmode of use of the instrument. The cable assembly generally includes aproximal end including an electrical connector for connecting theinstrument to a corresponding ultrasound console and current carryingwires extending distally from the electrical connector to the ultrasoundtransducer at least partially via a corresponding interior conduitformed in and extending longitudinally along the longitudinal shaft ofthe ultrasound probe. The current carrying wires also generally extendto the ultrasound transducer through the proximal end of the handle andthrough a corresponding interior conduit formed in and extendinglongitudinally along the longitudinal shaft of the handle.

The array of ultrasonic energy generation elements generally defines anaxial length along the longitudinal shaft of the ultrasound probe ofbetween about 8 millimeters and about 12 millimeters. In addition, thetactile feeler probe typically extends distally beyond the distal end ofthe longitudinal shaft of the ultrasound probe such that thelongitudinal shaft and the feeler probe tip of the tactile feeler probecollectively define an axial length of the tactile feeler probe beyondthe array of side-firing ultrasonic energy generation elements ofbetween about 8 millimeters and about 12 millimeters.

The present disclosure also advantageously provides a medical diagnosticsystem for use in conjunction with bone tissue that includes:

a medical diagnostic instrument, the instrument including (i) a handledisposed proximate an operator of the instrument, the handle beingconfigured and dimensioned to permit the operator to manually grasp theinstrument and manipulate the instrument relative to the spine of ahuman patient; (ii) an ultrasound probe that includes a longitudinalshaft extending distally from the handle and terminating in a distalend, and an ultrasound transducer mounted to the longitudinal shaftproximate the distal end thereof, the ultrasound transducer including anarray of side-firing ultrasonic energy generation elements extendingalong the longitudinal shaft, wherein the ultrasound transducer and thedistal end are cooperatively configured, oriented, and dimensioned topermit the operator to insert the ultrasound transducer and the distalend into a desired anatomical location (e.g., a pedicle screw pilot holeformed in the spine of the human patient) such that the array ofside-firing ultrasonic energy generation elements of the ultrasoundtransducer extends axially along, and is positioned against, a selectedportion of the anatomical location, (iii) a tactile feeler probe mountedwith respect to the ultrasound probe, the tactile feeler probe includinga longitudinal shaft mounted with respect to the longitudinal shaft ofthe ultrasound probe and extending distally therefrom beyond the distalend thereof, and a feeler probe tip defined at a distal end of thelongitudinal shaft of the tactile feeler probe, the feeler probe tip andthe longitudinal shaft of the tactile feeler probe being cooperativelyconfigured and dimensioned to permit the operator to insert the feelerprobe tip and the longitudinal shaft of the tactile feeler probe intothe desired anatomical location (e.g., a pedicle screw pilot hole) suchthat the feeler probe tip is positioned against the selected portion ofthe side wall of the pedicle screw pilot hole, and to permit theoperator to perform thereat a tactile inspection of the desiredanatomical location; and (iv) a first cable assembly for carryingelectrical signals to and from the ultrasound transducer in accordancewith an ultrasonic imaging mode of use of the instrument, the cableassembly including a proximal end including a first electrical connectorfor connecting the instrument to a corresponding ultrasound console andcurrent carrying wires extending distally from the electrical connector,through the longitudinal shaft of the ultrasound probe and to theultrasound transducer. The disclosed system may further include and/orbe adapted to operate with an ultrasound console including a processorfor controlling the medical diagnostic instrument, a display fordisplaying two-dimensional ultrasonic images obtained therefrom by anoperator thereof, and a port for receiving a corresponding cableconnector; and a second cable assembly for carrying electrical signalsto and from the ultrasound console, the second cable assembly includinga second electrical connector coupled to a the port associated with theultrasound console, a third electrical connector coupled to the firstelectrical connector, and current carrying wires extending therebetween.

Still further, the present disclosure provides an advantageous method ofexploring a desired anatomical location (e.g., a pedicle screw pilothole formed in the spine of a human patient for cortical breacheslocated in the axially-extending side-walls thereof) that includes:

presenting a medical diagnostic instrument that includes (i) a handle,(ii) an ultrasound probe that includes a longitudinal shaft extendingdistally from the handle and terminating in a distal end, and anultrasound transducer mounted to the longitudinal shaft proximate thedistal end thereof, the ultrasound transducer including an array ofultrasonic energy generation elements (e.g., side-firing) extendingalong the longitudinal shaft; and (iii) a tactile feeler probe mountedwith respect to the ultrasound probe, the tactile feeler probe includinga longitudinal shaft mounted with respect to the longitudinal shaft ofthe ultrasound probe and extending distally therefrom beyond the distalend thereof, and a feeler probe tip defined at a distal end of thelongitudinal shaft of the tactile feeler probe;

employing the handle to manually grasp and manipulate the medicaldiagnostic instrument relative to the desired anatomical location (e.g.,the spine of a human patient), including inserting the ultrasoundtransducer and the distal end of the longitudinal shaft of theultrasound probe, and the feeler probe tip and the longitudinal shaft ofthe tactile feeler probe into the desired anatomical location;

positioning the array of ultrasonic energy generation elements of theultrasound transducer relative to the desired anatomical location;

employing the array of ultrasonic energy generation elements of theultrasound transducer to obtain a two-dimensional image of the desiredanatomical location;

positioning the feeler probe tip of the tactile feeler probe relative tothe desired anatomical location;

employing the feeler probe tip of the tactile feeler probe to perform atactile inspection of the desired anatomical location; and

performing the two positioning and the two employing steps withoutremoving any of the ultrasound transducer or the distal end of thelongitudinal shaft of the tactile feeler probe or the feeler probe tipof the longitudinal shaft of the tactile feeler probe from the desiredanatomical location.

Additional features, functions and benefits of the present disclosurewill be apparent from the detailed description which follows,particularly when read in conjunction with the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectdisclosure appertains will more readily understand how to construct andemploy the systems, apparatus and methods of the subject disclosure,reference may be had to the drawings wherein:

FIG. 1 is schematic side elevational view of a medical diagnostic systemin accordance with the present disclosure, the system including amedical diagnostic instrument, an ultrasound console, and associatedcable assemblies for establishing communication therebetween;

FIGS. 2-7 are side elevational views of an exemplary medical diagnosticinstrument in accordance with the present disclosure;

FIG. 7A is a partial side elevational view of an alternative exemplarymedical diagnostic instrument in accordance with the present disclosure;

FIGS. 8 and 9 are side elevational and close-up side detail views,respectively, of a further embodiment of a medical diagnostic instrumentin accordance with the present disclosure;

FIGS. 10 and 11 are respective side elevational and side detail views ofa further exemplary embodiment of a medical diagnostic instrument inaccordance with the present disclosure;

FIGS. 12, 13 and 14 are top plan, side elevational, and bottom planviews, respectively, of an additional exemplary embodiment of a medicaldiagnostic instrument in accordance with the present disclosure;

FIG. 15 is a side elevational view of an exemplary embodiment of amedical diagnostic instrument in accordance with the present disclosurefor use in conjunction with a K-wire during minimally invasive spinesurgery;

FIG. 15A is a side elevational view of an exemplary embodiment of amedical diagnostic instrument similar to the instrument of FIG. 15 inaccordance with the present disclosure for use in conjunction with aK-wire (that may be introduced through alternative channels) duringminimally invasive spine surgery;

FIG. 16 is a side elevational view of another exemplary embodiment of amedical diagnostic instrument in accordance with the present disclosurefor use in conjunction with a K-wire during minimally invasive spinesurgery;

FIGS. 17, 18 and 19 illustrate various known spinal implantapplications;

FIGS. 20-25 illustrate various known screw placement techniques usedwith respect to different spinal levels;

FIGS. 26-28 (L2/3 Listhesis), FIGS. 29-31 (L2 Burst Fracture), FIGS.32-34 (L1 Burst Fracture), FIGS. 35-37 (Metastatic Bone Disease) andFIGS. 38-39 (Minimally Invasive Surgery) illustrate various examples ofinstrumented spine surgery in which the disclosed systems, apparatus andmethods may be used for the benefit of spinal patients suffering from avariety of spinal diseases, degenerative conditions and/or diseases;

FIGS. 40 and 41 illustrate existing technology for intra-operativelocation of breaches in the cortical bone tissue of spinal pedicles;

FIGS. 42-50 set forth information associated with tests conducted withrespect to animal vertebral bodies using an ultrasound probe inaccordance with embodiments of the present disclosure; and

FIGS. 51-55 set forth information associated with tests conducted withrespect to human cadaveric subjects in accordance with embodiments ofthe present disclosure;

FIGS. 56-57 are successive views of a medical diagnostic instrument inaccordance with the present disclosure being used in vivo to locatepotential pilot hole bone tissue defects prior to pedicle screwimplantation; and

FIGS. 58-59 are views of an implementation according to the presentdisclosure wherein a modified Jamshidi-style needle is used incombination with an ultrasound probe.

DESCRIPTION OF EXEMPLARY EMBODIMENT(S)

In accordance with embodiments of the present disclosure, advantageousmedical diagnostic instruments, systems and methods are provided for useduring a broad variety of spinal surgical applications. The presentdisclosure provides improved equipment and advantageous methods forcombining the comfort and familiarity of tactile inspection techniqueswith increasingly effective ultrasound imaging techniques to assistsurgeons, for example, in quickly and conveniently inspecting pilotholes for bone tissue defects prior to pedicle screw implantation.

Referring now to FIG. 1, a medical diagnostic system 101 in accordancewith embodiments of the present disclosure is shown. The system 101includes a medical diagnostic instrument 103 which may include a firstcable assembly 105. The system 103 also includes an ultrasound console107 and a second cable assembly 109.

The instrument 103 includes a handle 111. The handle 111 is disposableproximate an operator (not shown) of the instrument 103 and isconfigured and dimensioned to permit the operator (not shown) tomanually grasp the instrument 103, and to manipulate the instrument 103relative to the spine of a human patient (not shown).

The instrument 103 further includes an ultrasound probe 113. Theultrasound probe 113 includes a longitudinal shaft 115 extendingdistally from the handle 111 and terminating in a distal end 117. Theultrasound probe 113 further includes an ultrasound transducer 119mounted to the longitudinal shaft 115 proximate the distal end 117thereof. The ultrasound transducer 119 includes an array of side-firingultrasonic energy generation elements (not separately shown) extendingalong the longitudinal shaft 115.

The ultrasound transducer 119 and the distal end 117 are cooperativelyconfigured, oriented, and dimensioned to permit the operator (not shown)to insert the ultrasound transducer 119 and the distal end 117 into apedicle screw pilot hole (not shown) formed in the spine of the humanpatient (not shown) such that the array of side-firing ultrasonic energygeneration elements of the ultrasound transducer 119 extends axiallyalong, and is positioned against, a selected portion of a side wall (notshown) of the pedicle screw pilot hole, and to permit the operator toobtain thereat a corresponding two-dimensional image (not shown) of theselected portion of the side wall for visual inspection by the operatorfor purposes of detecting ultrasonically-detectable cortical breacheslocated therein (not shown).

The instrument 103 further includes a tactile feeler probe 121 mountedwith respect to the ultrasound probe 113, the tactile feeler probe 121including a longitudinal shaft 123 mounted with respect to thelongitudinal shaft 115 of the ultrasound probe 113 and extendingdistally therefrom beyond the distal end 117 thereof, and a feeler probetip 125 defined at a distal end 127 of the longitudinal shaft 123 of thetactile feeler probe 121, the feeler probe tip 125 and the longitudinalshaft 123 of the tactile feeler probe 121 being cooperatively configuredand dimensioned to permit the operator (not shown) to insert the feelerprobe tip 125 and the longitudinal shaft 123 of the tactile feeler probe121 into the pedicle screw pilot hole (not shown) such that the feelerprobe tip 125 is positioned against the selected portion of the sidewall of the pedicle screw pilot hole (not shown), and to permit theoperator to perform thereat a tactile inspection of the selected portionof the side wall of the pedicle screw pilot hole for purposes ofdetecting manually detectable cortical breaches located therein (notshown).

As indicated above, the instrument 103 may further include a first cableassembly 105. The first cable assembly 105 may be configured andarranged to carry electrical signals to and from the ultrasoundtransducer 119 in accordance with an ultrasonic imaging mode of use ofthe instrument 103. The first cable assembly 105 may include a proximalend 129 including a first electrical connector 131 for connecting theinstrument 103 to a corresponding ultrasound console 107 and currentcarrying wires (not separately shown) extending distally from theelectrical connector 131, through the longitudinal shaft 123 of theultrasound probe 113 and to the ultrasound transducer 119.

The ultrasound console 107 includes a processor 133 for controlling theinstrument 103, a display 135 for displaying two-dimensional ultrasonicimages obtained from the instrument 103 by an operator thereof, and aport 137 for receiving a corresponding cable connector.

As indicated above, the system 101 includes a second cable assembly 109for carrying electrical signals to and from the ultrasound console 107.The second cable assembly 109 includes a second electrical connector 139coupled to a the port 137 associated with the ultrasound console 107, athird electrical connector 141 coupled to the first electrical connector131, and current carrying wires (not separately shown) extendingtherebetween.

The connection between the third electrical connector 141 of the secondcable assembly 109 and the first electrical connector 131 of the firstcable assembly may be an umbilical connection between a disposableportion 143 of the medical diagnostic system 101 including the medicaldiagnostic instrument 103, and a non-disposable portion 145 of themedical diagnostic system 101 including the ultrasound console 107 andthe second cable assembly 109.

Turning now to FIGS. 1 and 2, the longitudinal shaft 123 of the tactilefeeler probe 121 may define a longitudinal axis 201 along which thelongitudinal shaft 123 of the tactile feeler probe 121 extends distallyfrom the longitudinal shaft 115 of the ultrasound probe 113, and alongitudinal axis 203 along which the longitudinal shaft 123 of thetactile feeler probe 121 extends distally to the feeler probe tip 125,and a bend 205 formed therebetween such that the longitudinal axis 201and the longitudinal axis 203 collectively define a first plane(represented in FIG. 2 by the plane in which FIG. 2 appears). Thelongitudinal shaft 115 of the ultrasound probe 113 may define alongitudinal axis 207 along which the longitudinal shaft 115 of theultrasound probe 113 extends distally from the handle 111. Theside-firing ultrasonic energy generation elements of the array thereof(not separately shown) may define a longitudinal axis 209 along whichthe array of side-firing ultrasonic energy generation elements extends.

As indicated in FIG. 2 at reference numeral 211, the longitudinal axis209 associated with the side-firing ultrasonic energy elements of thearray thereof may be radially offset from the longitudinal axis 207associated with the longitudinal shaft 115 of the ultrasound probe 113.In such circumstances, the longitudinal axis 207 and the longitudinalaxis 209 may collectively define a second plane (represented in FIG. 2by the plane in which FIG. 2 appears) that is coplanar with the firstplane.

As indicated in FIG. 2 at reference numeral 213, the feeler probe tip125 may be radially offset from the longitudinal axis 207 associatedwith the longitudinal shaft 115 of the ultrasound probe 113. In suchcircumstances, each of the feeler probe tip 125 and the longitudinalaxis 209 associated with the array of side-firing ultrasonic energygeneration elements may be offset from the longitudinal axis 207 in acommon radial direction therefrom such that the feeler probe tip 125 andthe array of side-firing ultrasonic energy generation elements arerotationally aligned with each other relative to the longitudinal shaft115 of the ultrasound probe 113. Alternatively (not shown in FIG. 2),the feeler probe tip 125 may be disposed on the longitudinal axis 207associated with the longitudinal shaft 115 of the ultrasound probe 113.

Still referring to FIG. 2, the handle 111 may include a longitudinalshaft 215 extending proximally from the ultrasound probe 113 andterminate in a proximal end 217. The longitudinal shaft 215 may define alongitudinal axis 219 along which the handle 111 extends proximally fromthe ultrasound probe 113. As shown in FIG. 2, the longitudinal axis 217may be disposed in the first plane (represented in FIG. 2 by the planein which FIG. 2 appears). In such circumstances, the longitudinal axis219 associated with the handle may be positioned and oriented coaxiallywith respect to the longitudinal axis 207 associated with thelongitudinal shaft 115 of the ultrasound probe 113 such that the handle211 and the ultrasound probe 113 are longitudinally aligned with eachother.

As indicated in FIG. 2 at reference numeral 221, the array ofside-firing ultrasonic energy generation elements may define an axiallength along the longitudinal shaft 115 of the ultrasound probe 113 ofbetween about 8 millimeters and about 12 millimeters. For example, thearray of side-firing ultrasonic energy generation elements may define anaxial length along the longitudinal shaft 115 of the ultrasound probe113 of about 10 millimeters.

As indicated in FIG. 2 at reference numeral 223, the tactile feelerprobe 121 extending distally beyond the distal end 117 of thelongitudinal shaft 115 of the ultrasound probe 113 may include whereinthe longitudinal shaft 123 and the feeler probe tip 125 of the tactilefeeler probe 121 may collectively define an axial length of the tactilefeeler probe 121 beyond the array of side-firing ultrasonic energygeneration elements of between about 8 millimeters and about 12millimeters. For example, the feeler probe tip 125 of the tactile feelerprobe 121 may collectively define an axial length of the tactile feelerprobe 121 beyond the array of side-firing ultrasonic energy generationelements of about 10 millimeters.

As indicated in FIG. 2 at reference numeral 225, the ultrasoundtransducer 119 and the distal end 117 being cooperatively configured,oriented, and dimensioned to permit the operator to insert theultrasound transducer 119 and the distal end 117 into a pedicle screwpilot hole formed in the spine of the human patient (not shown) includeswherein the ultrasound transducer 119 and the distal end 117 define atransverse width or diameter of between about 2 millimeters and 4millimeters. For example, the ultrasound transducer 119 and the distalend 117 define a transverse width or diameter of about 3 millimeters.

As shown in FIGS. 1 and 2, the feeler probe tip 125 may be a ball tip.The array of side-firing ultrasonic energy generation elementsassociated with the ultrasound transducer 119 may be a linear array.Alternatively, 17. the array of side-firing ultrasonic energy generationelements associated with the ultrasound transducer 119 may be a phasedarray. Other types of arrays are possible as well.

Turning now to FIG. 3, a medical diagnostic instrument 301 in accordancewith embodiments of the present disclosure is shown. The instrument 301may be structurally and functionally similar to the instrument 103discussed above with reference to FIGS. 1 and 2, with some differences.The instrument 301 includes a tactile feeler probe 303 that is mountedwith respect to the ultrasound probe 305 such that the longitudinalshaft 307 of the tactile feeler probe 303 is supported,cantilever-style, by the longitudinal shaft 309 of the ultrasound probe305. Also as shown, at least some longitudinal overlap exists betweenthe longitudinal shaft 307 of the tactile feeler probe 303 and thelongitudinal shaft 309 of the ultrasound probe. In the embodiment shownin FIG. 3, the longitudinal shaft 307 of the tactile feeler probe 303includes no major bends and is mounted atop the longitudinal shaft 309of the ultrasound probe 305.

Turning now to FIG. 4, a medical diagnostic instrument 401 in accordancewith embodiments of the present disclosure is shown. The instrument 401may be structurally and functionally similar to the instrument 103discussed above with reference to FIGS. 1 and 2, with some differences.The instrument 401 includes a tactile feeler probe 403 that is mountedwith respect to the ultrasound probe 405 such that the longitudinalshaft 407 of the tactile feeler probe 403 is supported,cantilever-style, by the longitudinal shaft 409 of the ultrasound probe405. Also as shown, at least some longitudinal overlap exists betweenthe longitudinal shaft 407 of the tactile feeler probe 403 and thelongitudinal shaft 409 of the ultrasound probe. In the embodiment shownin FIG. 3, the longitudinal shaft 407 of the tactile feeler probe 403includes no major bends. A proximal end 411 of the longitudinal shaft407 of the tactile feeler probe 403 is lodged within a complementarycavity 413 formed in the longitudinal shaft 409 of the ultrasound probe405 adjacent the distal end 415 thereof.

Referring now to FIG. 5, a medical diagnostic instrument 501 inaccordance with embodiments of the present disclosure is shown. Theinstrument 401 may be structurally and functionally similar to theinstrument 103 discussed above with reference to FIGS. 1 and 2, withsome differences. The instrument 501 includes no tactile feeler probe.Otherwise, the instrument 501 is configured and dimensionedsubstantially identically to the instrument 103.

A medical diagnostic instrument 601 in accordance with embodiments ofthe present disclosure is shown in FIG. 6. The instrument 601 isconfigured and dimensioned substantially identically to the instrument103, with differences as discussed below in the handle 603 of theinstrument 601 as compared to the handle 111 of the instrument 103. Thelongitudinal shaft 605 of the handle 603 defines a further longitudinalaxis 607 disposed in the plane of FIG. 6 and along which thelongitudinal shaft 605 of the handle 603 extends proximally to theproximal end 609 of the handle 603, and a bend 611 formed between thelongitudinal axis 607 and the longitudinal axis 613 such that an angledefined between the longitudinal axis 607 and the longitudinal axis 615is larger than an angle defined between the longitudinal axis 613 andthe longitudinal axis 615, and such that the handle 603 functions as abayonet handle relative to the ultrasound and feeler probes 617, 619.

Turning now to FIG. 7, a medical diagnostic instrument 701 in accordancewith embodiments of the present disclosure is shown. The instrument 701may be structurally and functionally similar to the instrument 601discussed above with reference to FIG. 6, with some differences. Theinstrument 701 includes no tactile feeler probe. Otherwise, theinstrument 701 is configured and dimensioned substantially identicallyto the instrument 601. Of note, the ultrasonic energy generationelements may be oriented on opposite sides of the ultrasound probe, aswill be apparent to persons skilled in the art. In addition, FIG. 7Ashows the distal end of an alternative version of the discloseddiagnostic medical instrument 701A in which the an array of ultrasonicenergy generation elements are axially aligned with the ultrasound probesuch that the ultrasound energy from the ultrasound probe is directedsubstantially axially, i.e., in a substantially forward direction.

FIGS. 8 and 9 include respective side and close-up cutaway side views ofa medical diagnostic instrument 801 in accordance with embodiments ofthe present disclosure. The instrument 801 may be structurally andfunctionally similar to the instrument 103 discussed above withreference to FIGS. 1 and 2, with some differences. The handle 803 of thediagnostic instrument 801 includes a housing 805. The ultrasonic probe807 is mounted with respect to the handle 803 such that the longitudinalshaft 809 of the ultrasonic probe 807 is supported, cantilever-style, bythe handle housing 805. The tactile feeler probe 811 is mounted withrespect to the ultrasound probe 807 such that the longitudinal shaft 813of the tactile feeler probe 811 is supported, cantilever-style, by thelongitudinal shaft 809 of the ultrasound probe 807. In accordance withsome embodiments of the present disclosure, including the embodimentshown in FIGS. 8 and 9, there is no overlap between the longitudinalshaft 809 of the ultrasound probe and the longitudinal shaft 813 of thetactile feeler probe 811. Instead, the tactile feeler probe 811 ismounted directly to the distal end 815 of the longitudinal shaft 809 ofthe ultrasound probe 807 via a proximal shoulder portion 817 of thetactile feeler probe 813.

Turning now to FIGS. 10 and 11, a medical diagnostic instrument 1001 inaccordance with embodiments of the present disclosure is shown. Theinstrument 1001 may be structurally and functionally similar to theinstrument 401 discussed above with reference to FIG. 4, with somedifferences. In accordance with some embodiments of the presentdisclosure, including the embodiment shown in FIGS. 10 and 11, there isno overlap between the longitudinal shaft 1003 of the ultrasound probe1005 and the longitudinal shaft 1007 of the tactile feeler probe 1009.Instead, the tactile feeler probe 1009 is mounted directly to the distalend 1011 of the longitudinal shaft 1003 of the ultrasound probe 1005 viaa proximal shoulder portion 1013 of the tactile feeler probe 100.

Referring now to FIGS. 12, 13 and 14, a medical diagnostic instrument1201 in accordance with embodiments of the present disclosure is shown.The instrument 1201 may be structurally and functionally similar to theinstrument 501 discussed above with reference to FIG. 5, with somedifferences. The longitudinal axis 1203 associated with the longitudinalshaft 1205 of the ultrasound probe 1207 may be radially offset from thelongitudinal axis 1209 associated with the longitudinal shaft 1211 ofthe ultrasound probe 1213.

Turning now to FIG. 15, a medical diagnostic instrument 1501 inaccordance with embodiments of the present disclosure is shown. Theinstrument 1501 may be structurally and functionally similar to theinstrument 601 discussed above with reference to FIG. 6, with certainadditional features. The handle 1503 of the diagnostic instrument 1501includes a housing 1505. In the housing 1505 of the handle 1503 isformed a channel 1507 configured and dimensioned to receive a K-wire1509 to permit the instrument 1501 to be slidably mounted thereto forpurposes of guiding the ultrasound and tactile feeler probes 1511, 1513axially relative to the pedicle screw pilot hole, including during aminimally invasive surgical procedure, the channel 1507 being formed inthe housing 1505 of the handle 1503 and extending through the handle1503.

With reference to FIG. 15A, an alternative medical diagnostic instrument1501A is shown in which handle 1503A includes a housing 1505A thatdefines first channel 1507A and second channel 1508A. Both channels1507A and 1508A are configured and dimensioned to receive a K-wire,e.g., K-wire 1509A and/or K-wire 1512A, to permit the instrument 1501Ato be slidably mounted thereto for purposes of guiding the ultrasoundand tactile feeler probes 1511A, 1513A axially relative to the pediclescrew pilot hole, including during a minimally invasive surgicalprocedure. Thus, the channels 1507A and 1508A are formed in the housing1505A of the handle 1503A and extend therethrough. In use, theoperator/surgeon would be free to select the channel to be used forK-wire introduction, e.g., based on whether the operator/surgeon desiresto see the K-wire pass the ultrasound probe.

Turning now to FIG. 16, a medical diagnostic instrument 1601 inaccordance with embodiments of the present disclosure is shown. Theinstrument 1601 may be structurally and functionally similar to theinstrument 601 discussed above with reference to FIG. 6, with certainadditional features. The handle 1603 of the diagnostic instrument 1601includes a housing 1605. A channel 1607 is configured and dimensioned toreceive a K-wire 1609 to permit the instrument 1601 to be slidablymounted thereto for purposes of guiding the ultrasound and tactilefeeler probes 1611, 1613 axially relative to the pedicle screw pilothole, including during a minimally invasive surgical procedure, thechannel 1607 being formed in an extension 1615 of the housing 1605 ofthe handle 1603 and extending past the handle 1603.

Variations and modifications of the above-described medical diagnosticinstruments are possible in accordance with embodiments of the presentdisclosure. In accordance with some such variations and modifications(not shown), the handle and the longitudinal shaft of the ultrasoundprobe are of unitary construction with respect to each other. Each ofthe above-described diagnostic instruments may be equipped with a cableassembly for carrying electrical signals to and from the ultrasoundtransducer in accordance with an ultrasonic imaging mode of use of theinstrument, the cable assembly including a proximal end including anelectrical connector for connecting the instrument to a correspondingultrasound console and current carrying wires extending distally fromthe electrical connector to the ultrasound transducer at least partiallyvia a corresponding interior conduit formed in and extendinglongitudinally along the longitudinal shaft of the ultrasound probe.Other variations and modifications are possible.

Thus, the present disclosure provides, inter alia, advantageouslyintegrated medical diagnostic instruments, systems incorporating suchinstruments, and methods of use of such instruments and systems for thebenefit of such surgical practitioners and their patients. Practitionersmay employ the presently disclosed technology in connection with a broadvariety of surgical applications, including with respect to any bone inthe human body in which a screw may be inserted. For example and/or inparticular, surgical practitioners may advantageously apply thepresently disclosed technology for the benefit of spine patients,including with respect to the specific application of intrapedicularscrew implantation.

Further details of the use of the presently disclosed technology withrespect to the specific application of intrapedicular screw implantationare provided hereinbelow. Based at least in part on the results oftesting performed in connection with the presently disclosed technology,the disclosed instruments, systems, and methods of the presentdisclosure can be seen to address a variety of compelling needs longfelt by surgical practitioners. For example, the presently disclosedtechnology addresses the perpetually growing demand on the part of suchprofessionals for effective instruments, systems and related surgicalmethods for use in connection with such applications as cervical spinesurgery, thoracic spine surgery, lumbar spine surgery, and sacral spinesurgery, including surgery performed for the benefit of patientssuffering from spinal trauma, spinal tumors, degenerative spinedisorders, scoliosis and other diseases and conditions.

Turning now to FIGS. 17, 18, and 19, various known spinal implantapplications are illustrated. A spinal implant 1701 shown in sideelevational view in FIG. 17, including at least one spinal support rod1703, is placed adjacent to and extending across multiple spinal levelsincluding L3, L2, L1, T12, T11 and T10 to compensate for deteriorationin or damage done to the L1 pedicle. Another spinal implant 1801 isshown in rear elevational view in FIG. 18, including angled andcross-connected spinal support rods 1803, 1805, each extending across acorresponding side of multiple spinal levels. A further spinal implant1901 is shown in side elevational view in FIG. 19, including a spinalsupport rod 1903 placed adjacent to and extending across spinal levelsL4, L3 and L2 to compensate for deterioration in or damage done to theL3 pedicle, such spinal implant 1901 including respective pedicle screws1905 affixed to the adjacent L2 and L4 pedicles. The presently disclosedtechnology may be employed in conjunction with any or all such spinalimplant applications, as well as spinal implant applications similarthereto.

Referring now to FIGS. 20, 21, 22, 23, 24 and 25, various known screwplacement techniques are shown for use with respect to different spinallevels, including with respect to a first pedicle 2001 shown in rearelevational, top plan and side elevational views in FIGS. 20, 21, and22, respectively, a second pedicle 2301 shown in rear elevational andtop plan views in FIGS. 23 and 24, respectively, and a third pedicle2501 shown in top plan view in FIG. 25. The presently disclosedtechnology may be employed in conjunction with any or all such pediclescrew placement techniques, as well as pedicle screw placementtechniques similar thereto.

Various case examples of instrumented spine surgery to which thepresently disclosed technology may be applied for the benefit of spinalpatients suffering from a variety of spinal diseases, degenerativeconditions and diseases, are shown in FIGS. 26-39. A spinal implant 2601is shown via FIGS. 26, 27 and 28, such implant having been implanted forthe benefit of a patient afflicted with an L2/3 listhesis. A spinalimplant 2901 is shown via FIGS. 29, 30 and 31, such implant having beenimplanted for the benefit of a patient that suffered an L2 burstfracture. A patient suffering from an L1 burst, including progressiveKyphosis, pain and paraparesis, may benefit from implantation of aspinal implant 3201, as shown in FIGS. 32, 33 and 34. A patientdiagnosed with metastatic bone disease may be treated with spinalsurgical apparatus 3501, as shown in FIGS. 35, 36 and 37. Images ofspinal surgical apparatus 3801, 3803 and 3805, and an associated spinalimplant 3901, are shown in FIGS. 38 and 39 (in which an example ofminimally invasive surgery is illustrated). As discussed, the presentlydisclosed technology may be employed in conjunction with such spinalimplant applications, as well as spinal implant applications similarthereto.

Referring now to FIGS. 40 and 41, existing technology for locatingbreaches in the cortical bone tissue of spinal pedicles is depicted.More particularly, diagnostic apparatus such as the apparatus 4001 maybe used with integrated display technology (such as a screen display4101) to implement a scheme for intraoperative monitoring of electricalcurrent with respect to a predetermined threshold, wherein observedcurrent in excess of the predetermined threshold is taken as a strongindication of the presence of an inappropriate cortical breach. However,the systems, apparatus and methods of the present disclosure offersuperior results and clinical benefits as compared to such prior arttechnology.

Referring now to information shown and described in FIGS. 42-50, testshave been performed with respect to animal vertebral bodies using a 2.7mm diameter ultrasound probe in accordance with embodiments of thepresent disclosure. Associated test materials are shown in FIG. 42,relevant anatomy is shown in FIG. 43, and associated testing methods areillustrated in FIG. 44. Large and small pedicle breaches are exemplifiedin images encompassed by FIG. 45. Examples of test materials presentingan intact pedicle (i.e., a pedicle having no breach in the side walls ofthe pedicle entry hole such as would result in the pedicle entry holecommunicating with the spinal canal) are shown in images encompassed byFIG. 46. Examples of experimental controls, including with respect tothe response of the probe in air and water, are shown in FIG. 47. Theimages of FIG. 48 show that no applicable signal was detected with thetest probe in the example of an intact pedicle with no breach. As shownin FIG. 49, employment of the test probe in conjunction with testmaterials in which a large pedicle breach was present resulted in thetest probe detecting such large breach. As shown in FIG. 50, employmentof the test probe in conjunction with test materials in which a smallpedicle breach was present resulted in the test probe detecting suchsmall breach.

Referring now to information shown and described in FIGS. 51-55, furthertests have been conducted with respect to human cadaveric subjects. FIG.51 illustrates a related test setup. As shown in images encompassed byFIG. 52, the tests included the use of a 3.18 mm side-firing ultrasoundprobe fitted with a detachable pedicle feeler/sounder in accordance withthe present disclosure. Various methods and techniques associated withthe human cadaveric tests are shown in the images encompassed by FIG.53. Some results corresponding to data collected and compared for ametal pedicle feeler (top) versus the use of pedicle ultrasound inaccordance with the techniques and apparatus of the present disclosureare shown in the images encompassed by FIG. 54. Further resultsexemplifying the diagnostic power of the techniques and apparatus of thepresent disclosure, are shown in the images encompassed by FIG. 55 andcorresponding respectively to: 1) a normal pedicle with no breach, 2) a2.5 mm pedicle breach, and 3) a 4.0 mm pedicle breach.

Test results with respect to 2.5 mm and 4.0 mm pedicle breaches andrelated explanatory information are set forth in the following tables.For purposes of the tables, the following terms are defined:Sensitivity=(# true pos.)/[(# true pos.)+(# false neg.)]Specificity=(# true neg.)/[(# true neg.)+(# false pos.)]Positive Predictive Value (PPV)=(# true pos.)/[(# true pos.)+(# falsepos.)]Negative Predictive Value (NPV)=(# true neg.)/[(# true neg.)+(# falseneg.)]

TABLE 1 Test Results; 2.5 mm Pedicle Breach Pedicle Pedicle PedicleFeeler Ultrasound #1 Ultrasound #2 Sensitivity 66.7% 85.7% 85.7%Specificity   80%   80%   80% PPV 85.7% 85.7% 85.7% NPV   57%   80%  80%

TABLE 2 Test Results; 4.0 mm Pedicle Breach Pedicle Pedicle PedicleFeeler Ultrasound #1 Ultrasound #2 Sensitivity 85.7%  100% 100%Specificity 100% 100% 100% PPV 100% 100% 100% NPV  80% 100% 100%

Based on the foregoing test results, including specifically the notedhuman cadaveric tests, the following conclusions have been reached:

-   -   The disclosed apparatus, systems and methods (pedicle        ultrasound) has a higher sensitivity and negative predictive        value as compared to the “classic” pedicle feeler.    -   The noted difference is greater with extremely small breaches        (2.5 mm vs. 4.0 mm)    -   With larger breaches (4.0 mm), the detection of breaches        approaches a sensitivity and specificity of 100% using the        pedicle ultrasound system.    -   The disclosed apparatus, systems and methods facilitate        screening tests and/or related diagnostics to determine/detect        whether a breach in cortical bone has occurred when placing        pedicle screws into the spine.    -   The disclosed apparatus, systems and methods allow surgeons and        other health care personnel to reduce the likelihood that        pedicle screws will be misplaced in spinal surgery, thereby        translating to more effective health care.

In operation, and as illustrated in FIGS. 56 and 57, the above describeddiagnostic instruments may be used to explore a pedicle screw pilot holeformed in the spine of a human patient for cortical breaches located inthe axially-extending side-walls thereof. As shown in FIGS. 56 and 57, amedical diagnostic instrument 6001 in accordance with the presentdisclosure is presented. The instrument includes a handle, an ultrasoundprobe, and a tactile feeler probe. The ultrasound probe includes alongitudinal shaft extending distally from the handle and terminating ina distal end, and an ultrasound transducer mounted to the longitudinalshaft proximate the distal end thereof. The ultrasound transducerincludes an array of side-firing ultrasonic energy generation elementsextending along the longitudinal shaft.

The tactile feeler probe is mounted with respect to the ultrasound probeand includes a longitudinal shaft mounted with respect to thelongitudinal shaft of the ultrasound probe and extending distallytherefrom beyond the distal end thereof. The tactile feeler probeincludes a feeler probe tip defined at a distal end of the longitudinalshaft of the tactile feeler probe.

The handle is employed to manually grasp and manipulate the medicaldiagnostic instrument relative to the spine of a human patient,including inserting the ultrasound transducer and the distal end of thelongitudinal shaft of the ultrasound probe, and the feeler probe tip andthe longitudinal shaft of the tactile feeler probe into a pedicle screwpilot hole formed in the spine of the human patient.

The feeler probe tip of the tactile feeler probe is positioned relativeto a selected portion of the side wall of the pedicle screw pilot holesuch that the feeler probe tip is positioned against the side wall ofthe pedicle screw pilot hole.

The feeler probe tip of the tactile feeler probe is employed to performa tactile inspection of the selected portion of the side wall forpurposes of detecting manually-detectable cortical breaches locatedtherein.

The array of side-firing ultrasonic energy generation elements of theultrasound transducer are positioned relative to selected portion of aside wall of the pedicle screw pilot hole such that the array ofside-firing ultrasonic energy generation elements extends axially along,and is positioned against, the selected portion of a side wall of thepedicle screw pilot hole.

The array of side-firing ultrasonic energy generation elements of theultrasound transducer is employed to obtain a two-dimensional image ofthe selected portion of the side wall for visual inspection for purposesof detecting ultrasonically-detectable cortical breaches locatedtherein.

The two positioning and the two array employment steps are performedwithout removing any of the ultrasound transducer or the distal end ofthe longitudinal shaft of the tactile feeler probe or the feeler probetip of the longitudinal shaft of the tactile feeler probe from thepedicle screw pilot hole.

The instrument may be mounted and slid along a K-wire (not specificallyshown) to guide the ultrasound and tactile feeler probes axiallyrelative to the pedicle screw pilot hole during a minimally invasivesurgical procedure. Alternatively, and/or in addition, the instrumentmay be mounted with respect to one or more guide wires other than aK-wire.

With reference to FIGS. 58-59, a further implementation according to thepresent disclosure is shown. Thus, a modified Jamshidi-style needleassembly 7001 may be employed with an ultrasound probe assembly inclinical applications, e.g., to detect/determine a breach in thecortical bone associated with pedicle screw placement. TheJamshidi-style needle assembly 7001 generally takes the form of a longhollow needle 7006 with a tapered cutting edge at a distal end thereof.A handle 7004 is mounted with respect to the needle 7006 and defines anaperture for receipt of an inner needle (not pictured) and ancillaryelement(s). In conventional use of a Jamshidi-style needle, the innerneedle may be removed once a desired anatomical location is reached anda syringe may be introduced through the aperture formed in the handlefor use in sampling tissue, e.g., bone marrow. However, in the exemplaryimplementation disclosed herein, after removal of the inner needle (notpictured), the aperture formed in handle 7004 of Jamshidi-style needleassembly 7001 is configured and dimensioned to receive an elongatedultrasound probe 7010 associated with ultrasound assembly 7002. Inexemplary implementations, the ultrasound assembly 7002 includes ahandle member 7008 that defines a fitting for connection to conventionalcabling.

In use, the Jamshidi-style needle assembly 7001 is introduced to adesired clinical location, e.g., within cortical bone that has beenpre-drilled for receipt of a pedicle screw, and the inner needle (notpictured) is removed. Ultrasound probe 7010 is then introduced throughthe aperture formed in the handle 7004 of the Jamshidi-style needleassembly 7001 for advantageous ultrasound detection of relevantinformation, e.g., a breach of the cortical bone. In exemplaryimplementations, needle 7006 is approximately 7.5 cm in length and theinner diameter of needle 7006 is approximately 3 mm. Alternativedimensions may be employed without departing from the spirit or scope ofthe present disclosure.

Although the systems, apparatus and methods have been described withrespect to exemplary embodiments herein, it is apparent thatmodifications, variations, changes and/or enhancements may be madethereto without departing from the spirit or scope of the invention asdefined by the appended claims. For example, as an alternative to theuse of a side-firing ultrasound transducer as described hereinabove,and/or in addition thereto, one or more end-firing ultrasoundtransducers, and/or 360 degree ultrasound transducers may be employed,whether mounted with respect to the distal end of the longitudinal shaftof the associated ultrasound probe, adjacent thereto, or otherwise, foruse as desired by the surgical practitioner. Ultrasound probes andsystems in accordance with the present disclosure may employ or embodyone or more of a variety of modes of ultrasound, including but notnecessarily limited to Ultrasound Mode A, Ultrasound Mode B, UltrasoundMode M, Ultrasound DM Mode, as well as color and three-dimensionalmodes. Other instruments may be modularly attached in addition to,and/or in place of a tactile feeler probe, including but not limited tocurettes, nerve hooks, Woodsons, and/or Murphey Balls. Accordingly, thepresent disclosure expressly encompasses all such modifications,variations, changes and/or enhancements.

1. A medical diagnostic instrument, comprising: a proximal handleconfigured and dimensioned to permit an operator to manually grasp theinstrument; an ultrasound probe including a longitudinal shaft extendingdistally from the handle and terminating in a distal end, and anultrasound transducer mounted with respect to the longitudinal shaftproximate the distal end thereof, the ultrasound transducer including anarray of ultrasonic energy generation elements; and a tactile feelerprobe mounted with respect to the ultrasound probe, the tactile feelerprobe including a longitudinal shaft mounted with respect to thelongitudinal shaft of the ultrasound probe and extending distally beyondthe distal end thereof, and a feeler probe tip defined at a distal endof the longitudinal shaft of the tactile feeler probe; wherein theultrasound transducer and the distal end are cooperatively configured,oriented, and dimensioned to permit the operator to insert theultrasound transducer and the distal end into a desired anatomicallocation to permit the operator to obtain thereat a correspondingtwo-dimensional image of the anatomical location for visual inspectionby the operator for purposes of detecting ultrasonically-detectableanatomical properties; and wherein the feeler probe tip and thelongitudinal shaft of the tactile feeler probe are cooperativelyconfigured and dimensioned to permit the operator to insert the feelerprobe tip and the longitudinal shaft of the tactile feeler probe intothe desired anatomical location to permit the operator to performthereat a tactile inspection of the selected anatomical location.
 2. Themedical diagnostic instrument of claim 1, wherein the desired anatomicallocation is a pedicle screw pilot hole formed in the spine of the humanpatient, and wherein the array of ultrasonic energy generation elementsof the ultrasound transducer extends axially along, and is positionedagainst, a selected portion of a side wall of the pedicle screw pilothole.
 3. The medical diagnostic instrument of claim 2, wherein thefeeler probe tip is positioned against the selected portion of the sidewall of the pedicle screw pilot hole.
 4. The medical diagnosticinstrument of claim 1, wherein the longitudinal shaft of the tactilefeeler probe defines at least a first longitudinal axis along which thelongitudinal shaft of the tactile feeler probe extends distally from thelongitudinal shaft of the ultrasound probe, at least a secondlongitudinal axis along which the longitudinal shaft of the tactilefeeler probe extends distally to the feeler probe tip, and a bend formedtherebetween such that the first and second longitudinal axescollectively define a first plane.
 5. The medical diagnostic instrumentof claim 4, wherein the longitudinal shaft of the ultrasound probedefines at least a third longitudinal axis along which the longitudinalshaft of the ultrasound probe extends distally from the handle, whereinthe ultrasonic energy generation elements of the array thereof define afourth longitudinal axis along which the array of ultrasonic energygeneration elements extends, wherein the fourth longitudinal axis isradially offset from the third longitudinal axis such that the third andfourth longitudinal axes collectively define a second plane, and whereinthe second plane is coplanar with the first plane.
 6. The medicaldiagnostic instrument of claim 5, wherein each of the feeler probe tipand the fourth longitudinal axis is offset from the third longitudinalaxis in a common radial direction therefrom such that the feeler probetip and the array of ultrasonic energy generation elements arerotationally aligned with each other relative to the longitudinal shaftof the ultrasound probe.
 7. The medical diagnostic instrument of claim1, wherein the longitudinal shaft of the ultrasound probe defines afirst longitudinal axis along which the longitudinal shaft of theultrasound probe extends distally from the handle, wherein theultrasonic energy generation elements of the array thereof define asecond longitudinal axis along which the array of ultrasonic energygeneration elements extends, wherein the second longitudinal axis is atleast partially disposed in radially spaced relation with respect to thefirst longitudinal axis such that the first and second longitudinal axescollectively define a first plane, and wherein the feeler probe tip isdisposed in the first plane.
 8. The medical diagnostic instrument ofclaim 7, wherein the feeler probe tip is disposed on the firstlongitudinal axis.
 9. The medical diagnostic instrument of claim 7,wherein the feeler probe tip is radially offset from the firstlongitudinal axis.
 10. The medical diagnostic instrument of claim 1,wherein the longitudinal shaft of the ultrasound probe defines a firstlongitudinal axis along which the longitudinal shaft of the ultrasoundprobe extends distally from the handle, wherein the ultrasonic energygeneration elements of the array thereof define a second longitudinalaxis along which the array of ultrasonic energy generation elementsextends, wherein the second longitudinal axis is radially offset fromthe first longitudinal axis such that the first and second longitudinalaxes define a first plane, wherein the handle includes a longitudinalshaft extending proximally from the ultrasound probe and terminating ina proximal end, the longitudinal shaft of the handle defining a thirdlongitudinal axis along which the handle extends proximally from theultrasound probe, the third longitudinal axis being disposed in thefirst plane.
 11. The medical diagnostic instrument of claim 10, whereinthe third longitudinal axis is positioned and oriented coaxially withrespect to the first longitudinal axis such that the handle and theultrasound probe are longitudinally aligned with each other.
 12. Themedical diagnostic instrument of claim 10, wherein the thirdlongitudinal axis is radially offset from the first longitudinal axissuch that the handle and the ultrasound probe are not longitudinallyaligned with each other.
 13. The medical diagnostic instrument of claim12, further comprising at least one channel configured and dimensionedto receive a K-wire to permit the instrument to be slidably mountedthereto for purposes of guiding the ultrasound and tactile feeler probesaxially relative to the desired anatomical location, the channel beingone of formed in the handle and extending therethrough, and formed in anextension of the handle and extending therepast.
 14. The medicaldiagnostic instrument of claim 12, wherein the longitudinal shaft of thehandle further defines a fourth longitudinal axis disposed in the firstplane and along which the longitudinal shaft of the handle extendsproximally to the proximal end of the handle, and a bend formed betweenthe third and fourth longitudinal axes such that an angle definedbetween the fourth and first longitudinal axes is larger than an angledefined between the third and first longitudinal axes, and such that thehandle functions as a bayonet handle relative to the ultrasound andfeeler probes.
 15. The medical diagnostic instrument of claim 1, whereinthe handle and the longitudinal shaft of the ultrasound probe are ofunitary construction with respect to each other.
 16. The medicaldiagnostic instrument of claim 1, wherein the handle includes a housing,and wherein the ultrasonic probe is mounted with respect to the handlesuch that the longitudinal shaft of the ultrasonic probe is supported,cantilever-style, by the handle housing.
 17. The medical diagnosticinstrument of claim 1, wherein the tactile feeler probe is mounted withrespect to the ultrasound probe such that the longitudinal shaft of thetactile feeler probe is supported, cantilever-style, by the longitudinalshaft of the ultrasound probe.
 18. The medical diagnostic instrument ofclaim 1, wherein at least some longitudinal overlap exists between thelongitudinal shaft of the tactile feeler probe and the longitudinalshaft of the ultrasound probe.
 19. The medical diagnostic instrument ofclaim 1, wherein the array of ultrasonic energy generation elements isside-firing and is one of a linear array and a phased array.
 20. Themedical diagnostic instrument of claim 1, further comprising a cableassembly for carrying electrical signals to and from the ultrasoundtransducer in accordance with an ultrasonic imaging mode of use of theinstrument, the cable assembly including a proximal end including anelectrical connector for connecting the instrument to a correspondingultrasound console and current carrying wires extending distally fromthe electrical connector to the ultrasound transducer at least partiallyvia a corresponding interior conduit formed in and extendinglongitudinally along the longitudinal shaft of the ultrasound probe. 21.The medical diagnostic instrument of claim 20, wherein the handleincludes a longitudinal shaft extending proximally from the ultrasoundprobe and terminating in a proximal end, wherein the current carryingwires extend to the ultrasound transducer through the proximal end ofthe handle and through a corresponding interior conduit formed in andextending longitudinally along the longitudinal shaft of the handle. 22.The medical diagnostic instrument of claim 1, wherein the array ofultrasonic energy generation elements defines an axial length along thelongitudinal shaft of the ultrasound probe of between about 8millimeters and about 12 millimeters.
 23. The medical diagnosticinstrument of claim 1, wherein the tactile feeler probe extendingdistally beyond the distal end of the longitudinal shaft of theultrasound probe includes wherein the longitudinal shaft and the feelerprobe tip of the tactile feeler probe collectively define an axiallength of the tactile feeler probe beyond the array of side-firingultrasonic energy generation elements of between about 8 millimeters andabout 12 millimeters.
 24. The medical diagnostic instrument of claim 1,wherein the feeler probe tip is a ball tip.
 25. A medical diagnosticsystem for use in conjunction with bone tissue, comprising: a medicaldiagnostic instrument, the instrument including: a handle, the handlebeing disposable proximate an operator of the instrument, the handlebeing further configured and dimensioned to permit the operator tomanually grasp the instrument and manipulate the instrument relative tothe spine of a human patient; an ultrasound probe, the ultrasound probeincluding a longitudinal shaft extending distally from the handle andterminating in a distal end, and an ultrasound transducer mounted to thelongitudinal shaft proximate the distal end thereof, the ultrasoundtransducer including an array of side-firing ultrasonic energygeneration elements extending along the longitudinal shaft, wherein theultrasound transducer and the distal end are cooperatively configured,oriented, and dimensioned to permit the operator to insert theultrasound transducer and the distal end into a pedicle screw pilot holeformed in the spine of the human patient such that the array ofside-firing ultrasonic energy generation elements of the ultrasoundtransducer extends axially along, and is positioned against, a selectedportion of a side wall of the pedicle screw pilot hole, and to permitthe operator to obtain thereat a corresponding two-dimensional image ofthe selected portion of the side wall for visual inspection by theoperator for purposes of detecting ultrasonically-detectable corticalbreaches located therein; a tactile feeler probe mounted with respect tothe ultrasound probe, the tactile feeler probe including a longitudinalshaft mounted with respect to the longitudinal shaft of the ultrasoundprobe and extending distally therefrom beyond the distal end thereof,and a feeler probe tip defined at a distal end of the longitudinal shaftof the tactile feeler probe, the feeler probe tip and the longitudinalshaft of the tactile feeler probe being cooperatively configured anddimensioned to permit the operator to insert the feeler probe tip andthe longitudinal shaft of the tactile feeler probe into the pediclescrew pilot hole such that the feeler probe tip is positioned againstthe selected portion of the side wall of the pedicle screw pilot hole,and to permit the operator to perform thereat a tactile inspection ofthe selected portion of the side wall of the pedicle screw pilot holefor purposes of detecting manually-detectable cortical breaches locatedtherein; and a first cable assembly for carrying electrical signals toand from the ultrasound transducer in accordance with an ultrasonicimaging mode of use of the instrument, the cable assembly including aproximal end including a first electrical connector for connecting theinstrument to a corresponding ultrasound console and current carryingwires extending distally from the electrical connector, through thelongitudinal shaft of the ultrasound probe and to the ultrasoundtransducer; an ultrasound console including a processor for controllingthe medical diagnostic instrument, a display for displayingtwo-dimensional ultrasonic images obtained therefrom by an operatorthereof, and a port for receiving a corresponding cable connector; and asecond cable assembly for carrying electrical signals to and from theultrasound console, the second cable assembly including a secondelectrical connector coupled to a the port associated with theultrasound console, a third electrical connector coupled to the firstelectrical connector, and current carrying wires extending therebetween.26. The medical diagnostic system of claim 25, wherein the connectionbetween the third electrical connector of the second cable assembly andthe first electrical connector of the first cable assembly is anumbilical connection between a disposable portion of the medicaldiagnostic system including the medical diagnostic instrument, and anon-disposable portion of the medical diagnostic system including theultrasound console and the second cable assembly.
 27. A method ofexploring a pedicle screw pilot hole formed in the spine of a humanpatient for cortical breaches located in the axially-extendingside-walls thereof, the method including: presenting a medicaldiagnostic instrument, the instrument including: a handle; an ultrasoundprobe, the ultrasound probe including a longitudinal shaft extendingdistally from the handle and terminating in a distal end, and anultrasound transducer mounted to the longitudinal shaft proximate thedistal end thereof, the ultrasound transducer including an array ofside-firing ultrasonic energy generation elements extending along thelongitudinal shaft; and a tactile feeler probe mounted with respect tothe ultrasound probe, the tactile feeler probe including a longitudinalshaft mounted with respect to the longitudinal shaft of the ultrasoundprobe and extending distally therefrom beyond the distal end thereof,and a feeler probe tip defined at a distal end of the longitudinal shaftof the tactile feeler probe; employing the handle to manually grasp andmanipulate the medical diagnostic instrument relative to the spine of ahuman patient, including inserting the ultrasound transducer and thedistal end of the longitudinal shaft of the ultrasound probe, and thefeeler probe tip and the longitudinal shaft of the tactile feeler probeinto a pedicle screw pilot hole formed in the spine of the humanpatient; positioning the array of side-firing ultrasonic energygeneration elements of the ultrasound transducer relative to a selectedportion of a side wall of the pedicle screw pilot hole such that thearray of side-firing ultrasonic energy generation elements extendsaxially along, and is positioned against, the selected portion of a sidewall of the pedicle screw pilot hole; employing the array of side-firingultrasonic energy generation elements of the ultrasound transducer toobtain a two-dimensional image of the selected portion of the side wallfor visual inspection for purposes of detectingultrasonically-detectable cortical breaches located therein; positioningthe feeler probe tip of the tactile feeler probe relative to theselected portion of the side wall of the pedicle screw pilot hole suchthat the feeler probe tip is positioned against the side wall of thepedicle screw pilot hole; employing the feeler probe tip of the tactilefeeler probe to perform a tactile inspection of the selected portion ofthe side wall for purposes of detecting manually-detectable corticalbreaches located therein; and performing the two positioning and the twoemploying steps without removing any of the ultrasound transducer or thedistal end of the longitudinal shaft of the tactile feeler probe or thefeeler probe tip of the longitudinal shaft of the tactile feeler probefrom the pedicle screw pilot hole.
 28. The method of claim 27, furthercomprising mounting and sliding the medical diagnostic instrument alonga K-wire to guide the ultrasound and tactile feeler probes axiallyrelative to the pedicle screw pilot hole during a minimally invasivesurgical procedure.